The plug helps decrease blood flow in the peripheral vasculature and is "completely re-sheathable" for use in procedures where a patient needs only temporary blood flow reduction.

"I’m very enthusiastic about our timing with this technology, as the Embolization market is poised for dramatic growth," Reverse president & CEO Jeffrey Valko said in prepared remarks. "We forecast more than 75,000 annual procedures in the US alone."

In addition to the FDA nod, Reverse also touted the 1st U.S. clinical cases of treatment with MVP, which the company called "impressive." The company has launched commercial efforts for the MVP device, citing "profound clinical success" demonstrated by its clinical evaluation study.

On December 12th, Rowe will sit down with MassDevice editor Brad Perriello for a long ranging discussion about the inside story on how these technologies came to market and what Rowe learned along the way.

Medical device and OEM company Millar said today it is selling its lifesciences telemetry product division to New Zealand-based Kaha Sciences. Houston-based Millar said the divestiture comes as the company looks to focus its efforts on the clinical and OEM business segments in a strategy that emerged earlier this year. Kaha Sciences has picked up a handful […]

InstruSafe by Summit Medical and Senhance Surgical Robotic System by TransEnterix have forged a partnership to launch two new surgical instrument trays. The two new trays will include an instrument tray an an endoscopic adapter tray that have been validated for the Senhance instrumentation. “We are excited to expand our product offering to include trays […]

By Stewart Eisenhart, Emergo Group New guidance from the US Food and Drug Administration explains requirements for in vitro diagnostic manufacturers to register for premarket notification using the agency’s Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]

Researchers are one step closer to creating a prosthetic hand that allows users to have full control over each finger, according to a new report from Georgia Tech. Researchers at the university say they have created an ultrasonic sensor which allows amputees to control individual fingers on a prosthetic hand, with enough sensitivity to play […]

Cadence has expanded its laser processing technologies with a new CL900 Cincinnati laser cutting machine. The new 4,000W fiber laser cutter adds to Cadence’s modified tube cutting lasers and completely custom flat sheet cutting lasers, Cadence announced yesterday. It also has the ability to cut 1,000 in. per minute (IPM) with a positioning accuracy of +/-0.001 […]

A team of biomedical engineers have developed a fully functioning artificial human heart muscle that can be used as a patch to repair dead heart muscle. Duke University biomedical engineers developed the patch to be used in human patients who have previously suffered a heart attack. “Right now, virtually all existing therapies are aimed at […]

Innovation is important in medtech and many other industries. But what does it really mean – and can it be done with speed? That was the question that a panel of experts – moderated by William Betten of Betten Solutions – grappled with today at DeviceTalks West in Orange County, Calif. It turns out that […]

Omnia Medical has received FDA 510(k) clearance for a vertebral body replacement (VBR) system for use in the thoracolumbar spine to replace collapsed, damaged or unstable vertebral body. The VBR system is manufactured from PEEK-Optima HA enhanced polymer through a collaboration with Jalex Medical on product development and regulatory activities and Invibio Biomaterial Solutions who […]

When it comes to dip molding products with emulsions of liquid rubber, it is necessary to complete a series of process steps to assure proper formation, vulcanization and finish treatment to meet the customer’s needs in the final application. Mark Agee, Kent Elastomer Products Dip molding can enable the creation of durable medical device parts in […]

GI Plastek, Precision Southeast and Plastics Solutions have merged to form PSI Molded Plastics. The three companies are owned by Gladstone Investment. The merger allows for PSI Molded Plastics to provide its customers injection molded component requirements in one place, including large to small parts from low to high volumes. The company will also provide […]